Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
In a dermal sensitisation study with Glyoxylic Acid 50% in acetone, 8 - 12 weeks old female Balb/c mice were tested using a combined Local Lymph Node Assay. The test concentrations were 1.25 , 2.5, 5.0, 10 , 20 or 40 %. Signs of skin irritation were seen at 40%. Glyoxylic Acid 50% tested positive in the LLNA with an EC3 value of 5.05% and a maximal stimulation index of 23.9 achieved at the 40% test concentration. Significant increases were observed in the B220+ cell population in the draining lymph nodes. No changes were identified in the IgE+B220+ cell population in the draining lymph nodes or total serum IgE levels; this suggests that Glyoxylic Acid 50% functions as a T-cell-mediated contact sensitizer (Anderson SE, 2008). In a dermal sensitisation study with Glyoxylic Acid in water young Pirbright white Guinea pigs (15 males) were tested using a method similar to Freund's complete adjuvant test (Induction: 10 injections intracutaneous, Challenge 80 % epicutaneous, open). In this study 100 % (15/15) of the animals treated with Glyoxylic acid showed a skin sensitization response. In this study, Glyoxylic acid is a potent dermal sensitiser (Hoechst, 1975).

Migrated from Short description of key information:
Glyoxylic acid was sensitising in the LLNA test and a guinea pig sensitisation test similar to Freund's complete adjuvant test.

Respiratory sensitisation

Endpoint conclusion
Additional information:
There are no human data available indicative of a respiratory sensitisation. Lymph node phenotyping performed in the LLNA published by Anderson (2008) suggested that the Glyoxylic acid response is a TH1 rather than a TH2 response, indicating no respiratory sensitising potential.

Migrated from Short description of key information:
There is no data available indicating a respiratory sensitising potential.

Justification for classification or non-classification

Based on the results of the sensitisation studies, Glyoxylic Acid 50% is subject to classification and labelling as follows:

R43 (may cause sensitisation by skin contact) according to Directive 67/548/EEC

Cat 1 / H317 ( may cause an allergic skin reaction) according to Regulation 1272/2008/EC.